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Immunogenicity and Safety of Inactivated Vero Cell Derived Japanese Encephalitis Vaccine in Thai Children (JE0153)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01408537
First Posted: August 3, 2011
Last Update Posted: November 18, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Pornthep Chanthavanich, Mahidol University
  Purpose

Japanese encephalitis (JE) is the main cause of viral encephalitis in many countries of Asia including Thailand. Estimated annual mortality ranges from10,000-15,000 deaths, while the total number of clinical cases is about 50,000. Of these cases, about 50% result in permanent neuropsychiatric sequelae. The disease occurs mostly among children aged <10 years. There is no specific antiviral treatment for JE. Vaccination is the single most important control measure. This study aims to evaluate the immunogenicity and safety of inactivated Vero cell derived JE vaccine (Beijing P-3 strain) produced by Liaoning Cheng Da Biotechnology Co., Ltd, China "JEVAC" in Thai children.

152 healthy Thai children aged between 1-3 years will be vaccinated with "JEVAC" in a dose of 0.5 mL. subcutaneously on Day 0, 1-4 weeks later and a booster vaccination at one year (totally 3 doses). Two mL. of blood will be drawn on Day 0, 4 weeks after second dose, at one year on booster vaccination day and 4 weeks after the booster (totally 8 mL. of 13 months study period) for determination of JE neutralizing antibodies (PRNT50) using Beijing P3 strain. Adverse events will be observed for 28 days after each vaccination. Serious adverse events will be observed throughout the study period.


Condition Intervention Phase
Encephalitis, Japanese B Biological: JEVAC Phase 3

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Immunogenicity and Safety of Inactivated Vero Cell Derived Japanese Encephalitis Vaccine in Thai Children

Resource links provided by NLM:


Further study details as provided by Pornthep Chanthavanich, Mahidol University:

Primary Outcome Measures:
  • Seroconversion Rate After Primary Vaccination [ Time Frame: 28 days after second dose of JEVAC ]
    To determine the seroconversion rate by using neutralizing antibody (NT) against JE virus (Beijing P3 strain) JE virus from <10 on before first vaccination To >= 10 at 28 days after second vaccination (primary vaccination). Those who have NT titer >=10 before first vaccination, will not be included in immunogenicity evaluation.


Secondary Outcome Measures:
  • Geometric Mean Titer of NT After Primary and Booster Vaccination [ Time Frame: 28 days after second vaccination, before and 28 days after booster vaccination with JEVAC ]
    To determine the geometric mean titers (GMT) of neutralizing antibody of JEVAC 1 month after primary and then before and after booster vaccinations.

  • Adverse Events of Vaccine [ Time Frame: 7, 14, 28 days after each vaccination and throughout the study period for local, solicited systemic, unsolicited systemic and serious adverse events, respectively ]
    To determine the adverse events of JEVAC

  • Neutralizing Antibody Persistence One Year After the Primary Vaccination [ Time Frame: 1 year after primary vaccination ]
    To determine the neutralizing antibody persistence one year after the primary JEVAC vaccination.


Enrollment: 152
Study Start Date: May 2010
Study Completion Date: December 2012
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: JEVAC
JEVAC 0.5 mL/ dose subcutaneously injected on upper thigh at D0, 1-4wk, and 1 year
Biological: JEVAC
Each subject will receive 3 doses of JEVAC subcutaneously on Day 0, 1-4 weeks and a booster vaccination at one year. Each dose of JEVAC contains 0.5 mL. of inactivated Vero cell derived JE vaccine (Beijing P-3 strain).

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   1 Year to 3 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Healthy Thai children aged 1- 3 years
  2. No previous history of JE vaccination
  3. Available for all visited schedule in the study period.
  4. Written inform consent signed by a parent or guardian

Exclusion Criteria:

  1. Known serious underlying diseases such as nervous system, heart, kidney and liver diseases.
  2. Known hypersensitivity to JE vaccine composition such as human albumin, dextran 40, etc.
  3. Previous history of JE disease.
  4. Receive the blood component within the past 3 months,
  5. Known history of immunocompromised conditions such as HIV/AIDS, malignancy.
  6. Under treatment of immunosuppressive drugs such as systemic corticosteroid and anti-neoplastic drug.
  7. Febrile illness (temperature ≥37.5°C) or acute illness/infection on the day of vaccination
  8. Plan to leave the study area before the end of study period.
  9. Participating in other clinical trials.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01408537


Locations
Thailand
Department Tropical Pediatrics
Ratchathewi, Bangkok, Thailand, 10400
Sponsors and Collaborators
Mahidol University
Investigators
Principal Investigator: Pornthep Chanthavanich, MD Department of Tropical Pediatrics, Faculty of Tropical Medicine, Mahidol University
  More Information

Responsible Party: Pornthep Chanthavanich, Department of Tropical Pediatrics, Faculty of Tropical Medicine, Mahidol University
ClinicalTrials.gov Identifier: NCT01408537     History of Changes
Other Study ID Numbers: JE0153
First Submitted: August 2, 2011
First Posted: August 3, 2011
Results First Submitted: April 23, 2013
Results First Posted: November 18, 2014
Last Update Posted: November 18, 2014
Last Verified: November 2014

Keywords provided by Pornthep Chanthavanich, Mahidol University:
inactivated Japanese encephalitis vaccine
vero cell
children
immunogenicity
safety

Additional relevant MeSH terms:
Encephalitis
Encephalitis, Japanese
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Encephalitis, Arbovirus
Arbovirus Infections
Virus Diseases
Encephalitis, Viral
Central Nervous System Viral Diseases
RNA Virus Infections
Flavivirus Infections
Flaviviridae Infections
Infectious Encephalitis
Central Nervous System Infections
Vaccines
Immunologic Factors
Physiological Effects of Drugs